ocally Advanced or Metastatic Hepatocellular Carcinoma (HCC): Evaluation of the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab

Phase 1

• Conditions: Hepatocellular Carcinoma; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2022-502948-13-00
• Lead Sponsor: Abbvie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-21
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Child-Pugh A ECOG PS 0-1 Received an immune checkpoint inhibitor in 1L HCC treatment regimen.No symptomatic, untreated, or actively progressing CNS metastases. Adequate hematologic and end-organ function Tissue biopsy at screening

Exclusion Criteria

No history of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%),, No major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study, No prior allogeneic stem cell or solid organ transplantation, Resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade = 1 prior to study entry, except for alopecia., Negative HIV test at screening due to potential safety concerns on those immune compromised patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To optimize livmoniplimab dose in combination with budigalimab and identify the recommended phase 3 dose in locally advanced or metastatic Child-Pugh A HCC patients who have progressed after an immune CPI-containing regimen in 1L HCC. To evaluate the efficacy of livmoniplimab in combination with budigalimab as measured by the rate of BOR of confirmed CR/PR determined by investigators.;Secondary Objective: To evaluate the efficacy of livmoniplimab in combination with budigalimab as measured by the DoR by investigators, PFS by investigators, and OS, To assess the safety, tolerability, immunogenicity, and PK of livmoniplimab in combination with budigalimab;Primary end point(s): The primary endpoint is the BOR of confirmed CR or confirmed PR per RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):The secondary endpoints are DoR by investigators, PFS by investigators, and OS.;Secondary end point(s):PFS by investigators: The time from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.;Secondary end point(s):OS: The time from randomization until death from any cause.